Bond between components of a medical device

ABSTRACT

An elongated member and a method of manufacturing an elongated member may include first, second, and third elongated rod mandrels. The first, second, and third elongated rod mandrels may be fixed together at predetermined proximal and distal locations and at a ball tip. The first, second, and third rod mandrels may be disposed within a tubular coupling element and fixed to the tubular coupling element at the ball tip. The tubular coupling element may be placed into abutment with and fixed to the distal end of an elongated shaft.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/676,653 now U.S. Pat. No. 8,940,014, filed Nov. 14, 2012, whichclaims the benefit to U.S. Provisional Application No. 61/559,892 filedNov. 15, 2011.

BACKGROUND

Medical devices typically used for cardiovascular system treatments mayinvolve complex and invasive therapies resulting in significantdiscomfort, pain, and long recovery times for patients. Recently, lessinvasive, percutaneous treatments have been developed. There is anongoing need for improved, less invasive cardiovascular treatments.

SUMMARY

A method of manufacturing an elongated member may comprise the steps ofobtaining first, second, and third elongated rod mandrels, a tubularcoupling element, and an elongated shaft, cutting the first, second, andthird elongated rod mandrels to a predetermined length, welding thefirst, second, and third elongated rod mandrels together at apredetermined distal location, welding the first, second, and thirdelongated rod mandrels together at a predetermined proximal location,disposing the first, second, and third elongated rod mandrels within alumen of the tubular coupling element, welding the proximal ends of thefirst, second, and third elongated rod mandrels together to form a balltip, sliding the tubular coupling element proximally into abutment withthe ball tip to form a joint, welding the tubular coupling element tothe ball tip about the circumference of the joint, disposing the tubularcoupling element in abutment with the distal end of the elongated shaftto form a second joint, and welding the tubular coupling element to thedistal end of the elongated shaft about the circumference of the secondjoint.

An elongated member may comprise a first elongated rod mandrel includinga first flattened distal portion, a second elongated rod mandrelincluding a second flattened distal portion, a third elongated rodmandrel including a third flattened distal portion, wherein the first,second, and third elongated rod mandrels are fixed together such thatthe first, second, and third flattened distal portions are arrangedperpendicular to radii extending out from the central longitudinal axisat 120-degree radial intervals, a coupling element having a lumentherethrough, and an elongate shaft, wherein the coupling member fixesthe first, second, and third elongated rod mandrels to the elongateshaft.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is side view of an example medical device system;

FIG. 2 is a cross-sectional side view of an example outer sheath;

FIG. 3 is a transverse cross-sectional view taken through line 3-3 inFIG. 2;

FIG. 4 is a side view of an example inner catheter;

FIG. 5 is a cross-sectional view taken through line 5-5 in FIG. 4;

FIG. 6 is a cross-sectional view taken through line 6-6 in FIG. 4;

FIG. 7 is a perspective view of a portion of an example implantassociated with the example medical device system;

FIGS. 8-11 are perspective views that illustrate an example mechanismfor locking an implant;

FIG. 12 is a side view of a portion of an example sheathing aid;

FIG. 13 is an enlarged plan view illustrating engagement of the examplesheathing aid with an example implant;

FIG. 14 is a side view of an example handle;

FIG. 15 is a cut away view illustrating some of the interior componentsof the example handle;

FIGS. 16-18 illustrate an example of coordinated movement of handlecomponents within the example handle;

FIGS. 19-20 illustrate the rotation of a collar on the example handle;

FIGS. 21-22 illustrate some of the components within the example handleduring rotation of the collar;

FIGS. 23-23A illustrate a partially-exploded view of some elements ofthe example medical system;

FIGS. 24-25 illustrate some steps of a method of manufacturing theelements of FIG. 23; and

FIGS. 26A-B illustrate example means of fastening the elements of FIG.23 to the example handle.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent in the United States and throughout the world.Traditionally, treatment of the cardiovascular system was oftenconducted by directly accessing the impacted part of the system. Forexample, treatment of a blockage in one or more of the coronary arterieswas traditionally treated using coronary artery bypass surgery. As canbe readily appreciated, such therapies are rather invasive to thepatient and require significant recovery times and/or treatments. Morerecently, less invasive therapies have been developed, for example,where a blocked coronary artery could be accessed and treated via apercutaneous catheter (e.g., angioplasty). Such therapies have gainedwide acceptance among patients and clinicians.

Some relatively common medical conditions may include or be the resultof inefficiency, ineffectiveness, or complete failure of one or more ofthe valves within the heart. For example, failure of the aortic valvecan have a serious effect on a human and could lead to serious healthcondition and/or death if not dealt with. Treatment of defective heartvalves poses other challenges in that the treatment often requires therepair or outright replacement of the defective valve. Such therapiesmay be highly invasive to the patient. Disclosed herein are medicaldevices that may be used for delivering a medical device to a portion ofthe cardiovascular system in order to diagnose, treat, and/or repair thesystem. At least some of the medical devices disclosed herein may beused to deliver and implant a replacement heart valve (e.g., areplacement aortic valve). In addition, the devices disclosed herein maydeliver the replacement heart valve percutaneously and, thus, may bemuch less invasive to the patient. The devices disclosed herein may alsoprovide a number of additional desirable features and benefits asdescribed in more detail below.

FIG. 1 is a side view of an example medical device system 10. It shouldbe noted that some features of system 10 are either not shown, or areshown schematically, in FIG. 1 for simplicity. Additional detailsregarding some of the components of system 10 are provided in otherfigures in greater detail. System 10 may be used to deliver and/ordeploy a variety of medical devices to a number of locations within theanatomy. In at least some embodiments, system 10 is a replacement heartvalve delivery system (e.g., a replacement aortic valve delivery system)that can be used for percutaneous delivery of a replacement heart valve.This, however, is not intended to be limiting as system 10 may also beused for other interventions including mitral valve replacement, valverepair, valvuloplasty, and the like, or other similar interventions.

System 10 may generally be described as a catheter system that includesan outer sheath or catheter 12 and an inner catheter or tube 14 (aportion of which is shown in FIG. 1 in phantom line) extending at leastpartially through outer sheath 12. A medical device implant 16 may becoupled to inner catheter 14 and disposed within outer sheath 12 duringdelivery of implant 16. A handle 18 may be disposed at the proximal endof outer sheath 12 and inner catheter 14. In general, handle 18 may beconfigured to manipulate the position of outer sheath 12 relative toinner catheter 14 as well as aid in the deployment of implant 16.

In use, system 10 may be advanced percutaneously through the vasculatureto a position adjacent to an area of interest. For example, system 10may be advanced through the vasculature to a position adjacent to adefective aortic valve. During delivery, implant 16 may be generallydisposed in an elongated and low profile “delivery” configuration withinouter sheath 12. Once positioned, outer sheath 12 may be retracted toexpose implant 16. Implant 16 may be actuated in order to expand implantinto a generally shortened and larger profile “deployed” configurationsuitable for implantation within the anatomy. When implant 16 issuitably deployed within the anatomy, system 10 can be removed from thevasculature, leaving implant 16 in place to function as, for example, asuitable replacement for the native aortic valve. In at least someinterventions, implant 16 may be deployed within the native valve (e.g.,the native valve is left in place and not excised). Alternatively, thenative valve may be removed and implant 16 may be deployed in its placeas a replacement.

FIGS. 2-13 (as well as other figures) illustrate some of the componentsof system 10. For example, FIG. 2 is a cross-sectional side view ofouter sheath 12. Here it can be seen that outer sheath 12 has a proximalportion 20 and a distal portion 22. Distal portion 22 may have aslightly enlarged or flared inner diameter, which may provide additionalspace for holding implant 16 therein. For example, the inner diameter ofouter sheath 12 along proximal portion 20 may be in the range of about0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), orabout 0.56388±0.0508 cm (0.222±0.002 inches). The inner diameter ofouter sheath 12 along distal portion 22 may be in the range of about0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), orabout 0.579 to 0.5842 cm (0.228 to 0.230 inches). At the distal end ofdistal portion 22 may be a distal tip 24, which may be flared orotherwise have a funnel-like shape. The funnel-like shape increases theouter diameter (and inner diameter) of outer sheath 12 at distal tip 24and may aid in the sheathing and/or re-sheathing of implant 16 intoouter sheath 12. Other than at distal tip 24, outer sheath 12 may have agenerally constant outer diameter. For example, outer sheath 12 may havean outer diameter in the range of about 0.254 to 1.27 cm (0.10 to 0.50inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.6858 cm (0.270inches). These are just examples. Other embodiments are contemplatedthat have differing dimensions (including those appropriate fordifferently sized patients including children) and/or arrangements forthe outer diameter and/or inner diameter of outer sheath 12. Thesecontemplated embodiments include outer sheaths with flared or otherwisevariable outer diameters, embodiments with constant inner diameters,combinations thereof, and the like. Outer sheath 12 may also have alength that is appropriate for reaching the intended area of interestwithin the anatomy. For example, outer sheath 12 may have a length inthe range of about 30 to 200 cm, or about 60 to 150 cm, or about 100 to120 cm, or about 108±0.20 cm. Outer sheath 12 may also be curved. Forexample, a distal section of outer sheath 12 may be curved. In oneexample, the radius of the curve (measured from the center of outersheath 12) may be in the range of about 2 to 6 cm (20 to 60 mm), orabout 3 to 4 cm (30 to 40 mm), or about 3.675 cm (36.75 mm). Again,these dimensions are examples and are not intended to be limiting.

Outer sheath 12 may be formed from a singular monolithic tube or unitarymember. Alternatively, outer sheath 12 may include a plurality of layersor portions. One or more of these layers may include a reinforcingstructure such as a braid, coil, mesh, combinations thereof, or thelike. FIG. 3 illustrates one example of a multilayer structure for outersheath 12. For example, outer sheath 12 may include an inner liner orlayer 26. An intermediate or tier layer 28 may be disposed on innerliner 26. A reinforcement 30 may be disposed on intermediate layer 28. Atopcoat or outer layer 32 may be disposed on reinforcement 30. Finally,an outer coating 34 (e.g., a lubricious coating, a hydrophilic coating,a hydrophobic coating, etc.) may be disposed along portions or all oftopcoat 32. These are just examples. Several alternative structuralconfigurations are contemplated for outer sheath 12 includingembodiments including two or more layers that may be different fromthose shown in FIG. 3, embodiments without a reinforcement, and thelike, or other suitable configurations.

The dimensions and materials utilized for the various layers of outersheath 12 may also vary. For example, inner liner 26 may include apolymeric material such as fluorinated ethylene propylene (FEP) and mayhave a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to0.005 inches) or about 0.00762±0.00254 (0.003±0.001 inches),intermediate layer 28 may include a polymer material such as polyetherblock amide (e.g., PEBAX 6333) and may have a thickness in the range ofabout 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about0.00508±0.00254 (0.002±0.001 inches), outer coating 34 may include apolymer material such as polyether block amide (e.g., PEBAX 7233) andmay have a thickness in the range of about 0.00254 to 0.0254 cm (0.001to 0.01 inches). In some embodiments, outer coating 34 may vary inthickness. For example, along proximal portion 20 outer coating 34 mayhave greater thickness, such as about 0.0127 to about 0.0508 cm or about0.02159 cm (0.005 to 0.02 inches or about 0.0085 inches), than alongdistal portion 22 and/or distal tip 24, which may be about 0.0127 toabout 0.0508 cm or about 0.01651 cm (e.g., about 0.005 to 0.02 inches orabout 0.0065 inches). These are just examples as other suitablematerials may be used.

The form of distal tip 24 may also vary. For example, in at least someembodiments, inner liner 26 (i.e., a 2.5 mm section thereof) may beextended up and around the distal end of outer sheath 12 (e.g., aroundreinforcement 30 and topcoat 32). A ring member (not shown) made from asuitable material such as a 55D polyether block amide (e.g., 55D PEBAX)may be disposed over inner liner 26 and heat bonded to form distal tip24. This may form the funnel-like shape of distal tip 24.

Reinforcement 30 may also vary in form. In at least some embodiments,reinforcement 30 may take the form of a braid, coil, mesh, or the like.For example, in some embodiments, reinforcement 30 may include ametallic braid (e.g., stainless steel). In some of these embodiments,reinforcement 30 may also include additional structures such as one ormore longitudinally-extending strands. For example, reinforcement 30 mayinclude a pair of longitudinally-extending aramid and/or para aramidstrands (for example, KEVLAR®) disposed on opposite sides of the braid.These strands may or may not be woven into portions or all of the braid.

FIG. 4 is a side view of the inner catheter 14. A distal end region ofinner catheter 14 may include a step in outer diameter 40 that defines adecreased outer diameter section 42. For example, decreased outerdiameter section 42 may have an outer diameter in the range of about0.127 to 0.635 cm (0.05 to 0.25 inches), or about 0.254 to 0.508 cm(0.10 to 0.20 inches), or about 0.38608±0.00762 (0.152±0.003 inches) asopposed to the remainder of inner catheter 14 where the outer diametermay be in the range of about 0.127 to 0.762 cm (0.05 to 0.30 inches), orabout 0.254 to 0.635 cm (0.10 to 0.25 inches), or about 0.508±0.0254 cm(0.20±0.01 inches). Decreased outer diameter section 42 may define aregion where other components of system 10 may be attached. Someadditional details regarding these components can be found herein.

In general, inner catheter 14 may take the form of an extruded polymertube. Other forms are also contemplated including other polymer tubes,metallic tubes, reinforced tubes, or the like including other suitablematerials such as those disclosed herein. In some embodiments, innercatheter 14 is a singular monolithic or unitary member. In otherembodiments, inner catheter 14 may include a plurality of portions orsegments that are coupled together. The total length of inner cathetermay be in the range of about 60 to 150 cm, or about 80 to 120 cm, orabout 100 to 115 cm, or about 112±0.02 cm. Just like outer sheath 12,inner catheter 14 may also be curved, for example adjacent to the distalend thereof. In some embodiments, inner catheter 14 may have one or moresections with a differing hardness/stiffness (e.g., differing shoredurometer). For example, inner catheter may have a proximal region 44 aand an intermediate region 44 b. Proximal region 44 a may include agenerally stiff polymeric material such as a 72D polyether block amide(e.g., 72D PEBAX) and may have a length in the range of about 60 to 150cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 109.5±0.02cm. Intermediate region 44 b may include a 40D polyether block amide(e.g., 40D PEBAX) and may have a length in the range of about 5 to 25mm, or about 10 to 20 mm, or about 15±0.01 mm. Decreased outer diametersection 42 may also differ from regions 44 a/44 b and, in someembodiments, may include a 72D polyether block amide (e.g., 72D PEBAX)and may have a length in the range of about 0.5 to 2 cm (5 to 20 mm), orabout 0.8 to 1.5 cm (8 to 15 mm), or about 1±0.001 cm (10±0.01 mm).These are just examples.

Inner catheter 14 may include one or more lumens. For example, FIG. 5(which is a cross-sectional view of inner catheter 14 adjacent toproximal end portion 36) illustrates that inner catheter 14 may includea first lumen 46, a second lumen 48, a third lumen 50, and a fourthlumen 52. In general, lumens 46/48/50/52 extend along the entire lengthof inner catheter 14. Other embodiments are contemplated, however, whereone or more of lumens 46/48/50/52 extend along only a portion of thelength of inner catheter 14. For example, fourth lumen 52 may stop justshort of the distal end of inner catheter 14 and/or be filled in at itsdistal end to effectively end fourth lumen 52 proximal of the distal endof inner catheter 14, as illustrated in FIG. 6 by the absence of fourthlumen 52 adjacent to the distal end of inner catheter 14.

Disposed within first lumen 46 may be push-pull rods 84 (not shown inFIG. 5, seen in other figures including FIG. 7), which are used toexpand and/or elongate implant 16 as explained in more detail herein. Inat least some embodiments, first lumen 46 may be lined with a lowfriction liner 54 (e.g., a FEP liner). Disposed within second lumen 48may be a pin release mandrel 92 (not shown in FIG. 5, seen in otherfigures including FIG. 7), which is also explained in more detailherein. In at least some embodiments, second lumen 48 may be lined witha hypotube liner 56. Third lumen 50 may be a guidewire lumen and thislumen may also be lined with a hypotube liner 58.

Fourth lumen 52 may be used to house a non-stretch wire 60. The form ofnon-stretch wire 60 may vary. In some embodiments, non-stretch wire 60may take the form of a stainless steel braid. The non-stretch wire 60may optionally include a pair of longitudinally-extending aramid and/orpara aramid strands (for example, KEVLAR®) disposed on opposite sides ofthe braid. In general, rather than being “disposed within” fourth lumen52, non-stretch wire 60 may be embedded within fourth lumen 52. Inaddition, non-stretch wire 60 may extend to a position adjacent todistal end portion 38 but not fully to the distal end of inner catheter14 as illustrated in FIG. 6 by the absence of fourth lumen 52 adjacentto the distal end of inner catheter 14. For example, a short distalsegment of fourth lumen 52 may be filled in with polymer materialadjacent to the distal end of inner catheter 14.

Inner catheter 14 may also include a guidewire extension tube 62 thatextends distally from distal end portion 38. A nose cone 64 is attachedto guidewire extension tube 62. Nose cone 64 generally is designed tohave an atraumatic shape. Nose cone 64 may also include a ridge or ledge66 that is configured to abut the distal tip 24 of outer sheath 12during delivery of implant 16.

FIG. 7 illustrates some of the additional components of system 10 andimplant 16. For example, here it can be seen that implant 16 includes aplurality of valve leaflets 68 (e.g., bovine pericardial) which aresecured to a cylindrical braid 70 at a post or commissure post 72, forexample at the commissure portions of the leaflets 68. In this example,implant 16 includes three leaflets 68 secured to braid 70 with threeposts 72. Leaflets 68 may also be secured to the base or “distal end” ofbraid 70. The posts 72, in turn, may be secured to braid 70 (e.g., alongthe interior of braid 70) with sutures or other suitable mechanisms.Positioned adjacent to (e.g., longitudinally spaced from and alignedwith) posts 72 are a plurality of buckles 76, which may also be suturedto braid 70 (e.g., along the interior of braid 70). In this example, onebuckle 76 is attached to braid 70 adjacent to each of the three posts72. Accordingly, braid 70 has a total of three buckles 76 and threeposts 72 attached thereto. Other embodiments are contemplated wherefewer or more buckles 76 and posts 72 may be utilized. A seal 74 (shownin cross-section) may be disposed about braid 70 and, as the namesuggests, may help to seal implant 16 within a target implant site orarea of interest.

Attachment between implant 16 and inner catheter 14 (and/or outer sheath12) may be effected through the use of a three finger coupler 78.Coupler 78 may generally include a cylindrical base (not shown) that isattached to inner catheter 14 (e.g., disposed about and attached toreduced outer diameter section 42). Projecting distally from the baseare three fingers that are each configured to engage with implant 16 atposts 72 and buckles 76. A collar 80 may further assist in holdingtogether these structures. A guide 82 may be disposed over each of thefingers and may serve to keep the fingers of coupler 78 associated withpush-pull rods 84 extending adjacent to coupler 78. Finally, a pinrelease assembly 86 may be a linking structure that keeps posts 72,buckles 76, and push-pull rods 84 associated with one another. Pinrelease assembly 86 includes a plurality of individual pins 88 that maybe joined together via a coiled connection 90 and held to a pin releasemandrel 92 with a ferrule 94.

During delivery, implant 16 is secured at the distal end of innercatheter 14 by virtue of the association of the fingers of coupler 78being coupled with a projecting proximal end of buckles 76 (and beingheld in place with collar 80 disposed over the connection) and by virtueof pins 88 securing together push-pull rods 84 and posts 72. Whenimplant 16 is advanced within the anatomy to the desired location, outersheath 12 may be withdrawn (e.g., moved proximally relative to innercatheter 14) to expose implant 16. Then, push-pull rods 84 can be usedto expand and “lock” implant 16 in the expanded or deployedconfiguration by proximally retracting push-pull rods 84 to pull posts72 into engagement with buckles 76. Finally, pins 88 can be removed,thereby uncoupling push-pull rods 84 from posts 72, which allows implant16 to be released from system 10 and deployed in the anatomy.

FIGS. 8-11 illustrate the locking system utilized with system 10. Forsimplicity purposes, only one of the three fingers of the coupler 78,only one of the three push-pull rods 84, and only one of the posts 72 ofthe example system 10 are shown (and implant 16 is not shown). As seenin FIG. 8, push-pull rod 84 extends through guide 82 adjacent to thefingers of coupler 78, through collar 80, through buckle 76, and into ahollow t-shaped bar portion 96 of post 72. The distal end of push-pullrod 84 may include an opening or aperture (not shown) that can bealigned with an opening 98 of t-shaped bar portion 96. When so aligned,pin 88 can be looped through opening 98 and the opening of push-pull rod84. This secures push-pull rod 84 to post 72 and forms a configurationof these structures that can be utilized during delivery of implant 16.As can be appreciated, the proximal end of post 72 and the distal end ofbuckle 76 are longitudinally separated and, accordingly, implant 16 isin an elongated and generally low-profile configuration suitable fordelivery.

When implant 16 reaches the intended target site within the anatomy, aclinician can proximally retract push-pull rod 84, thereby moving theproximal ends of posts 72 toward the distal ends of buckles 76 in orderto expand implant 16. Ultimately, push-pull rod 84 can be retractedsufficiently far enough to lock post 72 with buckle 76 so as to lockimplant in an expanded configuration suitable for implantation withinthe anatomy. FIG. 9 illustrates push-pull rod 84 proximally retracted.In doing so, post 72 is brought into contact with buckle 76. Moreparticularly, a raised, generally transversely-oriented ridge 100 ont-shaped bar portion 96 may be pulled proximally past buckle 76 so thatpost 72 is secured and held in place by buckle 76. At this point, it ispossible to urge push-pull rods 84 distally to “unlock” implant 16,thereby allowing for repositioning and/or retraction. Alternatively, ifa clinician is satisfied with the positioning and/or locking of implant16 (e.g., after visualization of implant 16 via a suitable imagingtechnique), pins 88 may be pulled (e.g., removed from openings 98 andthe openings in push-pull rods 84) to uncouple push-pull rods 84 fromposts 72 as shown in FIG. 10. Further retraction of push-pull rods 84causes a longitudinally-oriented ridge 102 on push-pull rods 84 toengage collar 80 and causes collar 80 to slide proximally along thefingers of coupler 78. In doing so, a forked end 104 of the fingers,which has a groove 106 formed therein, is exposed and can be uncoupledfrom a rail 108, which has a projection 110 formed thereon that isconfigured to mate with groove 106, as shown in FIG. 11. Thereafter,system 10 can be removed from the anatomy, leaving behind the expandedand deployed implant 16.

FIGS. 12-13 illustrate another component that may be included withsystem 10. For example, FIG. 12 is a side view of a portion of asheathing aid 112. Here it can be seen that sheathing aid 112 includes abase 114 and a group of petals including a set of three longer petals116 and a pair of shorter petals 118. In use, a group of petals 116/118may be positioned between each of the fingers of coupler 78. Because thecoupler 78 may have a total of three fingers, sheathing aid 112 may havea total of fifteen petals (e.g., three groups that each include three“long” petals 116 and two “short” petals 118, with each group beingpositioned between adjacent pairs of fingers of coupler 78). Base 114may be secured to inner catheter 14 adjacent to coupler 78 (e.g.,underneath coupler 78 and between coupler 78 and inner catheter 14).

Sheathing aid 112, as the name suggests, may be used to aid in thesheathing of implant 16 into outer sheath 12. In addition, sheathing aid112 may aid in the initial sheathing of implant 16 (e.g., removingimplant 16 from a packaging container such as a bottle and pullingimplant 16 into outer sheath 12) and in re-sheathing implant 16 duringrepositioning and/or retraction of implant 16 within the area ofinterest. Sheathing may be accomplished via the arrangement andpositioning of the various petals 116/118. For example, FIG. 13illustrates the longer petals 116 woven in and out of braid 70, and theshorter petals 118 disposed along the exterior of braid 70 acting as afunnel for sheathing.

FIG. 14 is a side view of handle 18. Here it can be seen that handle 18includes a handle housing 120. A rotatable control knob 122 may bedisposed about handle housing 120 (e.g., at a proximal end of handlehousing 120) and may be used to move one or more of the components ofsystem 10 (e.g., outer sheath 12, push-pull rods 84, etc.). A rotatablecollar 156 may be disposed about the handle housing 120. In someembodiments, control knob 122 may be disposed about a proximal portionof collar 156. A slidable door 124 may also be disposed about handlehousing 120. Door 124 may translate distally to expose a distal portionof rotatable collar 156 (not shown in FIG. 14, can be seen in otherfigures including FIGS. 19-20) positioned generally under door 124.Collar 156 may be rotated to move one or more components of system 10(e.g., push-pull rods 84, pin release mandrel 92, etc.). Handle 18 mayalso include one or more apertures 129 a/129 b and/or flush ports126/128 that can be used to flush system 10. In some embodiments, distalflush port 126 and proximal flush port 128 may be accessible from theexterior of the handle housing 120 through distal aperture 129 a andproximal aperture 129 b, respectively.

FIG. 15 is a side view of handle 18 with a portion of handle housing 120removed, exposing at least some of the interior components. Here it canbe seen that outer sheath 12 may be attached to a sheath adapter 130.Sheath adapter 130 is attached to a sheath carriage 132, which may bethreaded onto a lead screw 134. Distal flush port 126 may be disposed onsheath adapter 130. In general, distal flush port 126 provides access tothe interior or lumen of outer sheath 12 (e.g., access to space betweeninner catheter 14 and outer sheath 12) so that a clinician can flushfluid through the lumen of outer sheath 12 to remove any unwantedmaterials (e.g., air, fluid, contaminants, etc.) therein prior to use ofsystem 10. In at least some embodiments, distal flush port 126 has aluer type connector (e.g., a one-way luer connector) that allows adevice such as a syringe with a corresponding connector to be attachedthereto for flushing.

Extending through and proximally from sheath adapter 130 is innercatheter 14. A proximal end of inner catheter 14 is attached (e.g.,fixedly attached) to an interior body or diverter 136. Diverter 136 isattached to a support body 140. In general, diverter 136 and/or supportbody 140 may have one or more passageways or lumens formed therein. Insome embodiments, push-pull rods 84 and/or pin release mandrel 92 mayextend through respective passageways. Alternatively, the proximal endsof push-pull rods 84 and/or pin release mandrel 92 may each be attachedto a shaft or hypotube (e.g., solid in cross-section, tubular, etc.),and each of the shafts may extend through the one or more passageways.For example, a first shaft or hypotube 142 and a second shaft orhypotube 144 may extend through the passageways in diverter 136, and insome embodiments, the first shaft or hypotube 142 extends through afirst passageway and the second shaft or hypotube 144 extends through asecond passageway that is separate or distinct from the firstpassageway. In at least some embodiments, first shaft 142 is attached topin release mandrel 92. In at least some embodiments, second shaft 144is attached to push-pull rods 84. It should be noted that at in leastsome embodiments of system 10, three push-pull rods 84 are utilized. Inthese embodiments, the three push-pull rods 84 come together (e.g.,brought into contact with one another or otherwise brought intorelatively close proximity with one another) adjacent to the distal endof inner catheter 14 and enter first lumen 46. At one or more positionsalong their length, push-pull rods 84 may be attached to one another.For example, in some embodiments, push-pull rods 84 may be weldedtogether about 10.16 cm (about 4.00 inches) from their distal ends. Insome embodiments, push-pull rods 84 may be welded together proximatetheir proximal ends in addition to or instead of the distal weld.Proximally thereafter, push-pull rods 84 may extend to second shaft 144.

A hypotube (e.g., hypotube liner 58 disposed along guidewire lumen 52)may extend through diverter 136 within a passageway therein and then be“diverted” around a portion of diverter 136 and support body 140, andultimately be extended to a position at the proximal end of handle 18 soas to provide a user access to guidewire lumen 52. Proximal flush port128 may be disposed on support body 140 that can be used to flush thelumens of inner catheter 14 and, for example, may function similarly todistal flush port 126.

At their respective proximal ends, first shaft 142 may be secured to aslider 146 and second shaft 144 may be secured to a force limiter body150. The connections between the various components may include a numberof different types of connections including mechanical bonding (e.g.,pinning, threading, interference fit, etc.), adhesive bonding, thermalbonding, etc. Slider 146 may be slidable relative to force limiter body150. In some embodiments, slider 146 may be selectively locked to forcelimiter body 150, thereby preventing relative movement between theslider 146 and the force limiter body 150. Force limiter body 150 may besecured to a push-pull rod carriage 152, which may be threaded onto leadscrew 134. Thus, movement of lead screw 134 can cause movement ofpush-pull rod carriage 152 and force limiter body 150 and thus,push-pull rods 84 (via second shaft 144). Some additional detailsregarding this motion can be found herein.

In general, force limiter body 150 forms or defines a stop point thatprovides tactile feedback (e.g., resistance to further rotation ofcontrol knob 122) to the user indicating that push-pull rods 84 havebeen retracted proximally a sufficient distance to lock posts 72 withbuckles 76. To verify proper locking, a clinician may use an appropriatevisualization technique to visualize proper locking (e.g., the relativepositioning of the posts 72 and the buckles 76). A chock 148 may bepositioned adjacent to slider 146 to selectively lock slider 146 toforce limiter body 150. In order to allow pin release mandrel 92 to beproximally retracted to pull pins 88, chock 148 can be rotated orotherwise moved to a secondary position or configuration. When in thisconfiguration, chock 148 no longer forms a barrier to further movementof, for example, slider 146 and pin release mandrel 92. Accordingly,with chock 148 no longer acting as an impediment, slider 146 and pinrelease mandrel 92 can be proximally retracted to facilitate deploymentof implant 16 by allowing pins 88 to be pulled.

Handle 18 also includes a rotatable ring 155 with internal teeth thatare configured to engage with teeth on a gear 157 coupled to lead screw134. Ring 155 is coupled to control knob 122 so that rotation of controlknob 122 results in analogous motion of ring 155 and thus lead screw134.

Handle 18 is generally configured for coordinated movement of multiplestructures of system 10. For example, handle 18 is configured to allow auser to move outer sheath 12 (e.g., relative to inner catheter 14), movepush-pull rods 84, and move pin release mandrel 92. Moreover, handle 18is configured so that the appropriate structure can be moved at theappropriate time during the intervention so that implant 16 can bedelivered in an efficient manner. Some examples of how the coordinatedmovement of system 10 may occur within handle 18 may be similar to thosedisclosed in U.S. Patent Application Pub. No. US 2010/0280495, theentire disclosure of which is herein incorporated by reference.

To help facilitate the coordinated movement, handle 18 may include alost motion barrel 158. Lost motion barrel 158 is configured to engagecarriages 132/152 and/or screws associated with carriages 132/152 atdifferent times during the intervention to stop motion (e.g., create“lost motion” of the appropriate carriage). FIGS. 16-19 illustrate someof the coordinated motion achieved by handle 18. It should be noted thatsome elements of system 10 are not shown in FIGS. 16-20 for clarity. Forexample, FIG. 16 illustrates a first position or state for handle 18where outer sheath 12 is extended distally relative to inner catheter 14(and handle 18) so as to fully sheath (e.g., contain) implant 16. Whilein this position, sheath carriage 132 is positioned adjacent to thedistal end of handle 18. In addition, a rod screw 152 a associated withpush-pull rod carriage 152 is extended distally from push-pull rodcarriage 152 and positioned within lost motion barrel 158. Upon rotationof control knob 122 (e.g., in the clockwise direction), lead screw 134begins to rotate. Rotation of lead screw 134 causes sheath carriage 132to move along lead screw 134 in the proximal direction, resulting inproximal movement of outer sheath 12 (e.g., “unsheathing” implant 16).This initial rotation of lead screw 134 also causes rod screw 152 a torotate. This may be because, for example, a knob or projection (notshown) on rod screw 152 a may be engaged with a helical thread disposedalong the interior of lost motion barrel 158. However, because rod screw152 a is spaced from push-pull rod carriage 152, it does not exert aforce onto push-pull rod carriage 152. Thus, initial motion of controlknob 122 does not result in movement of push-pull rod carriage 152 and,instead, only results in translation of sheath carriage 132 and rotation(and translation) of rod screw 152 a.

Eventually, rod screw 152 a (e.g., the knob formed therein) reaches anessentially linear thread or pathway formed at the end of lost motionbarrel 158. The linear thread allows rod screw 152 a to translate alonglead screw 134 to a position where rod screw 152 a contacts (e.g., isthreaded within and abuts) push-pull rod carriage 152. In doing so, rodscrew 152 a can contact and move proximally push-pull carriage 152.Accordingly, further rotation of lead screw 134 not only causes sheathcarriage 132 to move proximally but also causes push-pull rod carriage152 to move proximally as shown in FIG. 17.

When sheath carriage 132 reaches lost motion barrel 158, a sheathcarriage screw 132 a of sheath carriage 132 enters lost motion barrel158 as shown in FIG. 18. This may occur in a manner similar to how rodscrew 152 a threads and unthreads with the helical thread formed alonglost motion barrel 158. For example, while sheath carriage 132 istranslating, sheath carriage screw 132 a may follow an essentiallylinear thread or pathway formed along or adjacent to lost motion barrel158. Upon reaching lost motion barrel 158, sheath carriage screw 132 a(e.g., a knob or projection formed thereon) may shift into engagementwith the helical thread within lost motion barrel 158 and rotate. Thisrotation “unthreads” sheath carriage screw 132 a from sheath carriage132. Accordingly, additional rotation of lead screw 134 results incontinued proximal movement of push-pull rod carriage 152 while motionof sheath carriage 132 ceases.

In at least some embodiments, lead screw 134 has a plurality ofportions, for example a first portion 134 a and a second portion 134 b,with a differing pitch to its thread. This may allow carriages 132/152to travel at different rates along lead screw 134. For example, thepitch of lead screw 134 along which sheath carriage 132 translates maybe generally more spaced or slanted than at positions adjacent topush-pull rod carriage 152. Accordingly, the coordinated movement ofcarriages 132/152 also may be configured so that sheath carriage 132translates along lead screw 134 at a greater rate than push-pull rodcarriage 152. Other configurations are contemplated where theabove-mentioned configuration is reversed as well as furtherconfigurations where the pitch of lead screw 134 is essentially constantor includes a number of different pitch regions.

Sufficient proximal retraction of push-pull rod carriage 152, forexample as shown in FIG. 18, may result in push-pull rods 84 beingsufficiently retracted so that posts 72 can engage and lock with buckles76. When the clinician is satisfied that locking is complete (e.g.,after verification via an appropriate visualization technique), theclinician may proximally retract pin release mandrel 92 in order to pullpins 88 from openings 98 and openings in push-pull rods 84 to releaseimplant 16.

To initiate release of pins 88, door 124 may be slid distally along acollar 156 (which is positioned on handle 18) as shown in FIG. 19. Whendoor 124 is sufficiently advanced, door 124 and collar 156, together,can be rotated as shown in FIG. 20. Push-pull rod carriage 152 may alsoinclude a radially-extending proximal flag member 164. In general, flagmember 164 may be designed as a feature that can prevent collar 156 frombeing rotated earlier than desired (and, thus, prevent pins 88 frombeing pulled earlier than desired). For example, flag member 164 may bepositioned within and follow a groove (not shown) along the interior ofcollar 156. While positioned within the groove, flag member 164essentially forms a physical barrier that prevents collar 156 fromrotating relative to handle housing 120. When push-pull rod carriage 152is translated proximally to the back of handle housing 120 (e.g., whenpush-pull rods 84 are proximally retracted so as to lock posts 72 withbuckles 76), flag member 164 exits the groove in collar 156.Accordingly, flag member 164 no longer impedes rotation of collar 156and, as such, collar 156 can now be rotated to pull pins 88.

Collar 156, via ring 154, is associated with a gear 160 engaged with asecondary screw 162. Notches at a proximal end of collar 156 engageprotrusions on ring 154 such that rotation of collar 156 causescorresponding rotation of ring 154 and thus secondary screw 162. Theinitial rotation of collar 156 is sufficient to rotate chock 148 (e.g.,via a mechanical interaction between collar 156 and chock 148 thatcauses chock 148 to shift) from a first configuration where slider 146(and, thus, pin release mandrel 92) is selectively locked to forcelimiter body 150, to a secondary configuration, which permits slider 146to translate along secondary screw 162 as secondary screw 162 rotates,to proximally retract and pull pins 88 (e.g., via pin release mandrel92). As seen in FIG. 21, chock 148 in the first configuration engages aridge 168 along a top portion of force limiter body 150 which forms aphysical barrier that prevents proximal translation of slider 146relative to force limiter body 150. When collar 156 is rotated to shiftchock 148 into the secondary configuration, slider 146 can translateproximally within a groove 166 disposed in the top portion of forcelimiter body 150 (e.g., as seen in FIG. 22), as collar 156 is rotatedabout the handle housing 120 to pull the pins 88 from the openings 98and the openings in the distal ends of the push-pull rods 84. Once pins88 have been removed, push-pull rods 84 may be withdrawn from implant16, thereby deploying the implant at the target site (area of interest).

Following deployment of the implant 16, the control knob 122 may berotated to move the sheath carriage 132 distally within the handlehousing 120, thereby moving outer sheath 12 distally relative to innercatheter 14 and three-finger coupler 78 so as to cover or re-sheath theelements of the medical device system 10 disposed at the distal end.Medical device system 10 may then be removed from the patient's anatomy.

FIGS. 23-26B illustrate additional details related to push-pull rods 84.For example, as seen in FIG. 23, an elongated member may comprise threepush-pull rods 84 formed from a first elongated rod mandrel, a secondelongated rod mandrel, and a third elongated rod mandrel. The first,second, and third elongated rod mandrels may be made of a metallicmaterial, such as Elgiloy®, nickel-titanium alloy, stainless steel, andthe like, or other suitable corrosion-resistant materials. In someembodiments, each of the rod mandrels may be made of the same metallicmaterial, or each or some of the rod mandrels may be made of different,but similar, compatible materials. Each of the elongated rod mandrelsmay include a respective flattened distal portion 200 (e.g., a firstflattened distal portion, a second flattened distal portion, etc.) at adistal end thereof, the flattened distal portion 200 having an openingtherethrough disposed proximate the distal end. Longitudinally-orientedridge 102 may be disposed adjacent to, or may extend from, a proximalsection of flattened distal portion 200.

As can be seen in FIG. 23, the first, second, and third elongated rodmandrels may be joined together to form a ball tip 206. Ball tip 206 maybe formed, for example, by welding the first, second, and thirdelongated rod mandrels together at their respective proximal ends usinga suitable welding method such as laser welding, GTAW (TIG) welding,spot welding, and the like. The first, second, and third elongated rodmandrels may also be joined or fixed together at other locations. Insome embodiments, the first, second, and third elongated rod mandrelsmay be welded together at a predetermined proximal location 202,proximate the proximal ends of the first, second, and third elongatedrod mandrels. In some embodiments, the first, second, and thirdelongated rod mandrels may be welded together at a predetermined distallocation 204, near the distal ends of the first, second, and thirdelongated rod mandrels. In some embodiments, the predetermined distallocation 204 may be located about 10.16 cm (about 4.00 inches) from thedistal ends of the first, second, and third elongated rod mandrels. Insome embodiments, the predetermined proximal location 202 may be locatedabout 1.33 cm (about 0.525 inches) from the proximal ends of the first,second, and third elongated rod mandrels. In some embodiments, thefirst, second, and third elongated rod mandrels may be welded togetherin both of the predetermined proximal and distal locations as describedabove, or in other suitable locations.

In some embodiments, the first, second, and third elongated rod mandrelsmay be fixed together such that each of their respective flatteneddistal portions 200 are arranged at generally equal intervals about acentral longitudinal axis, as seen in FIG. 23A. For example, the first,second, and third flattened distal portions 200 may be arrangedgenerally perpendicular to radii extending outwardly from the centrallongitudinal axis at about 120-degree radial intervals, such that thelongitudinally-oriented ridges 102 are aligned with the radii and arearranged at about 120 degrees relative to each other about the centrallongitudinal axis. In some embodiments, the first, second, and thirdelongated rod mandrels may have slack and twist removed as they arearranged into a desired orientation prior to fixing together at thepredetermined proximal location 202 and/or the predetermined distallocation 204. In these embodiments, the predetermined proximal location202 and/or the predetermined distal location 204 may maintain thedesired orientation of the push-pull rods 84 relative to each otherwhile reducing twisting and slack in the push-pull rods 84, andcontrolling and improving timing features during operation of themedical device system 10.

A tubular coupling element 210, shown in FIGS. 24-25, may provide ameans to join or fix the push-pull rods 84 to the second shaft 144.Tubular coupling element 210 may include a lumen 216 extendingtherethrough. The push-pull rods 84 may be disposed within the lumen 216such that the proximal ends of the push-pull rods 84 are exposedproximally of the tubular coupling element 210. Ball tip 206 may beformed at the proximal ends of the push-pull rods 84 as described above.Tubular coupling element 210 may be moved proximally relative topush-pull rods 84 such that a proximal end face of the tubular couplingelement 210 abuts the ball tip 206 to form a joint or seam 208, as seenin FIG. 24. The joint 208 may be welded around its circumference to fixthe tubular coupling element 210 to the ball tip 206 and push-pull rods84. In some embodiments, the tubular coupling element 210 and the balltip 206 may be welded about the entire circumference of the joint 208 bylaser welding, GTAW (TIG) welding, or other suitable welding techniques.Alternatively, joint 208 may be secured by adhesive or thermal bonding,mechanical bonding, or other suitable techniques.

Tubular coupling element 210 may include a stepped outer surface. Thetubular coupling element 210 may include a proximal portion 212 having afirst outer diameter adjacent a proximal end, and a distal portion 214having a second outer diameter adjacent a distal end. In someembodiments, the second outer diameter may be greater than the firstouter diameter. Preferably, the second outer diameter is about the sameor less than an outer diameter of second shaft 144. Second shaft 144 mayinclude a hypotube having a lumen extending therethrough, or a solid rodhaving a counterbore disposed within a distal end. The first outerdiameter may be about the same or slightly smaller than an innerdiameter of the lumen or counterbore of the second shaft 144, such thatthe proximal portion 212 may be inserted into or disposed within thelumen or the counterbore of the second shaft 144, with the distalportion 214 placed into abutment with a distal end of the second shaft144 to form a second joint 218, as seen in FIG. 25. The second joint 218may be welded around its circumference to fix the tubular couplingelement 210 to the second shaft 144. In some embodiments, the tubularcoupling element 210 and the second shaft 144 may be welded togetherabout the entire circumference of the second joint 218 by laser welding,GTAW (TIG) welding, or other suitable welding techniques. Alternatively,joint 218 may be secured by adhesive or thermal bonding, mechanicalbonding, or other suitable techniques.

In some embodiments, the tubular coupling element 210 and/or the secondshaft 144 may be made of metallic materials, such as Elgiloy®,nickel-titanium alloy, stainless steel, and the like, or other suitablecorrosion-resistant materials. In some embodiments, each of the tubularcoupling element 210 and the second shaft 144 may be made of the samemetallic material, or the tubular coupling element 210 and the secondshaft 144 may be made of different, but similar, compatible materials.

In some embodiments, the second shaft 144 may include a fastening meansdisposed at a proximal end thereof to facilitate attachment to the forcelimiter body 150. In some embodiments, the proximal end of the secondshaft 144 may be modified by drilling a hole 222 transversely throughthe second shaft 144, as seen in FIG. 26A. When the second shaft 144 isinserted into a bore in a distal end of the force limiter body 150, apin, screw, or other fastener may be inserted through hole 222 to fixsecond shaft 144 to force limiter body 150. In some embodiments, theproximal end of the second shaft 144 may be modified by cutting externalthreads 224 into an outer surface of the second shaft 144, as seen inFIG. 26B. In these embodiments, the second shaft 144 may be threadedinto a bore disposed in the distal end of force limiter body 150. Athreaded connection permits minor adjustments to be made to theorientation of the various components while still providing a secureconnection, reduces the overall number of components, and may reduce thetime and cost of assembly of the device. Alternatively, other suitablefastening means are contemplated, such as a press or interference fit, asnap-lock, or other positively-locking engagement between thecomponents, any or all of which may offer the same benefits oradvantages described above.

In some embodiments, a method of manufacturing is provided. The methodmay include providing or obtaining first, second, and third elongatedrod mandrels (e.g., push-pull rods 84), a tubular coupling element 210,and an elongated shaft (e.g., second shaft 144), each having a proximalend and a distal end. The first, second, and third elongated rodmandrels may be rough cut to a predetermined length. For example, thepredetermined length may be about 114.3-127 cm (about 45-50 inches) orabout 121.92 cm (about 48 inches). Next, the first, second, and thirdelongated rod mandrels may be finish cut to about 121.22 cm (about47.725 inches). The finish cut may be made by cutting, grinding, orother suitable methods. The first, second, and third elongated rodmandrels may be welded together at a predetermined distal location 204,which may be located about 10.16 cm (about 4.00 inches) from the distalends of the first, second, and third elongated rod mandrels. Afterwelding at the predetermined distal location 204, the first, second, andthird elongated rod mandrels may be welded together at a predeterminedproximal location 202, which may be located near the proximal ends ofthe first, second, and third elongated rod mandrels. In someembodiments, after welding at the predetermined distal location 204 andprior to welding at the predetermined proximal location 202, slack andtwist may be removed from the first, second, and third elongatedmandrels. The first, second, and third elongated rod mandrels may bedisposed within a lumen 216 of the tubular coupling element 210. Theproximal ends of the first, second, and third elongated rod mandrels maybe welded together to form a ball tip 206. After welding ball tip 206,the tubular coupling element 210 may be slid proximally along the first,second, and third elongated rod mandrels into abutment with the ball tip206, thereby forming a joint 208 having a circumference. The tubularcoupling element 210 may be welded to the ball tip 206 by welding aboutthe circumference of the joint 208. In some embodiments, the tubularcoupling element 210 may be welded to the ball tip 206 about the entirecircumference of the joint 208. Next, the tubular coupling element 210may be disposed in abutment with the distal end of the elongated shaftto form a second joint 218 having a circumference. In some embodiments,the tubular coupling element 210 includes a stepped outer surface havinga first outer diameter portion adjacent the proximal end (e.g. proximalportion 212) and a greater, second outer diameter portion adjacent thedistal end (e.g., distal portion 214). The second outer diameter portionmay be disposed in abutment with the distal end of the elongated shaftto form the second joint 218. In some embodiments, the first outerdiameter portion may be inserted into the distal end of the elongatedshaft. The tubular coupling element 210 may be welded to the distal endof the elongated shaft by welding about the circumference of the secondjoint 218. In some embodiments, the tubular coupling element 210 may bewelded to the distal end of the elongated shaft about the entirecircumference of the second joint 218. In some embodiments, the methodmay further comprise modifying the proximal end of the elongated shaftto include a fastening means. Modifying the proximal end of theelongated shaft to include a fastening means may consist of drilling ahole 222 transversely through the elongated shaft, or cutting externalthreads 224 into an outer surface of the elongated shaft. In someembodiments, the method may further comprise arranging the flatteneddistal end portions 200 of the first, second, and third elongated rodmandrels at radially equal intervals of about 120 degrees about acentral longitudinal axis.

The welding methods described above may provide increased consistencyand repeatability in joining the various elements, as well as reducedmanufacturing time, compared to some manual fixation or other bondingmethods. While the features and methods described above are discussed inrelation to joining the push-pull rods 84 and the second shaft 144 inparticular, the features and methods above may be equally applied toother aspects of the medical device system 10, such as joining the pinrelease mandrel 92 and the first shaft 142.

The materials that can be used for the various components of system 10(and/or other systems disclosed herein) and the various tubular membersdisclosed herein may include those commonly associated with medicaldevices. For simplicity purposes, the following discussion makesreference to outer sheath 12 and/or inner catheter 14. However, this isnot intended to limit the devices and methods described herein, as thediscussion may be applied to other similar tubular members and/orcomponents of tubular members or devices disclosed herein.

Outer sheath 12 and/or inner catheter 14 may be made from a metal, metalalloy, polymer (some examples of which are disclosed below), ametal-polymer composite, ceramics, combinations thereof, and the like,or other suitable material. Some examples of suitable metals and metalalloys include stainless steel, such as 304V, 304L, and 316LV stainlesssteel; mild steel; nickel-titanium alloy such as linear-elastic and/orsuper-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of outer sheath 12 andinner catheter 14 may also be doped with, made of, or otherwise includea radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. This relatively bright image aids the user of system 10 indetermining its location. Some examples of radiopaque materials caninclude, but are not limited to, gold, platinum, palladium, tantalum,tungsten alloy, polymer material loaded with a radiopaque filler, andthe like. Additionally, other radiopaque marker bands and/or coils mayalso be incorporated into the design of system 10 to achieve the sameresult.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into system 10. For example, outer sheath 12and inner catheter 14, or portions thereof, may be made of a materialthat does not substantially distort the image and create substantialartifacts (i.e., gaps in the image). Certain ferromagnetic materials,for example, may not be suitable because they may create artifacts in anMRI image. Outer sheath 12 and inner catheter 14, or portions thereof,may also be made from a material that the MRI machine can image. Somematerials that exhibit these characteristics include, for example,tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such asELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenumalloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, andthe like, and others.

A sheath or covering (not shown) may be disposed over portions or all ofouter sheath 12 and inner catheter 14 that may define a generally smoothouter surface for system 10. In other embodiments, however, such asheath or covering may be absent from a portion of all of system 10,such that outer sheath 12 and inner catheter 14 may form an outersurface. The sheath may be made from a polymer or other suitablematerial. Some examples of suitable polymers may includepolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the exterior surface of the system 10 (including,for example, the exterior surface of outer sheath 12 and inner catheter14) may be sandblasted, beadblasted, sodium bicarbonate-blasted,electropolished, etc. In these as well as in some other embodiments, acoating, for example a lubricious, a hydrophilic, a protective, or othertype of coating may be applied over portions or all of the sheath, or inembodiments without a sheath over portion of outer sheath 12 and innercatheter 14, or other portions of system 10. Alternatively, the sheathmay comprise a lubricious, hydrophilic, protective, or other type ofcoating. Hydrophobic coatings such as fluoropolymers provide a drylubricity which improves device handling and device exchanges.Lubricious coatings improve steerability and improve lesion crossingcapability. Suitable lubricious polymers are well known in the art andmay include silicone and the like, hydrophilic polymers such ashigh-density polyethylene (HDPE), polytetrafluoroethylene (PTFE),polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxyalkyl cellulosics, algins, saccharides, caprolactones, and the like, andmixtures and combinations thereof. Hydrophilic polymers may be blendedamong themselves or with formulated amounts of water insoluble compounds(including some polymers) to yield coatings with suitable lubricity,bonding, and solubility. Some other examples of such coatings andmaterials and methods used to create such coatings can be found in U.S.Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein byreference.

The coating and/or sheath may be formed, for example, by coating,extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusingseveral segments end-to-end. The layer may have a uniform stiffness or agradual reduction in stiffness from the proximal end to the distal endthereof. The gradual reduction in stiffness may be continuous as by ILCor may be stepped as by fusing together separate extruded tubularsegments. The outer layer may be impregnated with a radiopaque fillermaterial to facilitate radiographic visualization. Those skilled in theart will recognize that these materials can vary widely withoutdeviating from the scope of the present invention.

The entire disclosures of the following documents are hereinincorporated by reference in their entirety:

U.S. Patent Application Pub No. US 2007/0112355,

U.S. Patent Application Pub No. US 2010/0219092,

U.S. Patent Application Pub No. US 2010/0280495,

U.S. patent application Ser. No. 12/578,447, filed on Oct. 13, 2009 andentitled “Medical Devices and Delivery Systems for Delivering MedicalDevices”,

U.S. Patent Application Ser. No. 61/559,914, filed on Nov. 15, 2011 andentitled “Duel Sterilization Containment Vessel”,

U.S. Patent Application Ser. No. 61/559,941, filed on Nov. 15, 2011 andentitled “Medical Device With One Or More Sheathing Transition Members”,

U.S. Patent Application Ser. No. 61/559,871, filed on Nov. 15, 2011 andentitled “Medical Device with Nosecone and Nosecone Tube Extension”,

U.S. Patent Application Ser. No. 61/558,095, filed on Nov. 10, 2011 andentitled “Direct Connect Flush System”,

U.S. Patent Application Ser. No. 61/559,931, filed on Nov. 15, 2011 andentitled “Medical Device With Keyed Locking Structures”,

U.S. Patent Application Ser. No. 61/566,615, filed on Dec. 3, 2011 andentitled “Medical Device Handle”,

U.S. Patent Application Ser. No. 61/577,845, filed on Dec. 20, 2011 andentitled “Medical Device Handle”,

U.S. Patent Application Ser. No. 61/577,880, filed on Dec. 20, 2011 andentitled “Apparatus for Endovascularly Replacing a Heart Valve”,

U.S. Patent Application Ser. No. 61/577,891, filed on Dec. 20, 2011 andentitled “Heart Valve Replacement Catheter”, and

U.S. Patent Application Ser. No. 61/543,521, filed on Oct. 5, 2011 andentitled “Profile Reduction Seal”.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A medical device, comprising: an elongated handle housing having a control knob disposed about a proximal portion thereof, the control knob being rotatable with respect to the handle housing; a movable member disposed within the handle housing and operatively connected to the control knob, wherein rotation of the control knob with respect to the handle housing causes longitudinal movement of the movable member within the handle housing; and an elongated member fixed to the movable member, wherein the elongated member extends distally from the handle housing; wherein the elongated member includes a plurality of elongated rod mandrels configured to releasably engage with a medical implant; wherein the plurality of elongated rod mandrels is fixed together at one or more locations distal of the movable member; wherein the plurality of elongated rod mandrels includes a first elongated rod mandrel including a first flattened distal portion, a second elongated rod mandrel including a second flattened distal portion, and a third elongated rod mandrel including a third flattened distal portion; wherein the plurality of elongated rod mandrels is welded together at a proximal end thereof to form a ball tip.
 2. The medical device of claim 1, wherein the first, second, and third flattened distal portions are arranged perpendicular to radii extending out from a central longitudinal axis of the elongated member at 120-degree radial intervals.
 3. The medical device of claim 1, further including a coupling element having a lumen therethrough.
 4. The medical device of claim 3, wherein the plurality of elongated rod mandrels is disposed within the lumen.
 5. The medical device of claim 3, wherein the elongated member further includes an elongate shaft extending distally from the movable member, wherein the coupling element fixes the plurality of elongated rod mandrels to the elongate shaft.
 6. The medical device of claim 5, wherein a proximal portion of the coupling element is inserted into a distal end of the elongate shaft such that a distal portion of the coupling element abuts the distal end of the elongate shaft to form a joint.
 7. The medical device of claim 6, wherein an outer extent of the distal portion is substantially equivalent to an outer extent of the elongate shaft.
 8. The medical device of claim 1, wherein the medical implant includes a replacement heart valve.
 9. The medical device of claim 1, wherein the elongated member includes a transverse hole extending therethrough, and the elongated member is fixed to the movable member using a fastener extending through the transverse hole and at least a portion of the movable member.
 10. The medical device of claim 1, wherein the elongated member includes a threaded proximal end configured to engage with the movable member.
 11. The medical device of claim 1, wherein the elongated member is configured to shift the medical implant between a collapsed delivery configuration and an expanded deployed configuration.
 12. The medical device of claim 11, wherein rotation of the control knob causes longitudinal translation of the elongated member, thereby causing the medical implant to shift between the collapsed delivery configuration and the expanded deployed configuration. 